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TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

NCT03057860 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2800

Last updated 2022-05-09

No results posted yet for this study

Summary

About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.

Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.

Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).

Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).

Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.

In this situation, clinical registries can provide valuable information for evidence-based clinical decision making.

Extension of TREATgermany to children and adolescents is necessary as

* moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood
* it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone
* innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria
* adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group
* Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care

Conditions

Interventions

OTHER

No study intervention

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Jochen Schmitt, Prof.Dr. · Center for Evidence-based Healthcare, Technical University Dresden

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057860 on ClinicalTrials.gov